儿童非适应证精神药理学处方：历史支持密切临床监测。
Off-label psychopharmacologic prescribing for children: history supports close clinical monitoring.
机构信息
Pharmaceutical Health Services Research, School of Pharmacy, University of Maryland, Baltimore, Maryland, USA.
出版信息
Child Adolesc Psychiatry Ment Health. 2008 Sep 15;2(1):24. doi: 10.1186/1753-2000-2-24.
Abstract
The review presents pediatric adverse drug events from a historical perspective and focuses on selected safety issues associated with off-label use of medications for the psychiatric treatment of youth. Clinical monitoring procedures for major psychotropic drug classes are reviewed. Prior studies suggest that systematic treatment monitoring is warranted so as to both minimize risk of unexpected adverse events and exposures to ineffective treatments. Clinical trials to establish the efficacy and safety of drugs currently being used off-label in the pediatric population are needed. In the meantime, clinicians should consider the existing evidence-base for these drugs and institute close clinical monitoring.
摘要
这篇综述从历史角度介绍了儿科药物不良反应，并重点关注了与儿童精神科治疗中药物标签外使用相关的选定安全问题。审查了主要精神药物类别的临床监测程序。先前的研究表明，有必要进行系统的治疗监测，以尽量减少意外不良事件的风险和接触无效治疗的风险。需要进行临床试验以确定目前在儿科人群中标签外使用的药物的疗效和安全性。在此期间，临床医生应考虑这些药物的现有证据基础，并进行密切的临床监测。
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本文引用的文献
1
A surveillance method for the early identification of idiosyncratic adverse drug reactions.
Drug Saf. 2008;31(2):169-80. doi: 10.2165/00002018-200831020-00006.
2
Antipsychotic use in children and adolescents: minimizing adverse effects to maximize outcomes.
J Am Acad Child Adolesc Psychiatry. 2008 Jan;47(1):9-20. doi: 10.1097/chi.0b013e31815b5cb1.
3
Psychotropic medication patterns among youth in foster care.
Pediatrics. 2008 Jan;121(1):e157-63. doi: 10.1542/peds.2007-0212.
4
Retrolental fibroplasia; incidence in different localities in recent years and a correlation of the incidence with treatment given the infants.
J Am Med Assoc. 1949 Feb 26;139(9):572-8. doi: 10.1001/jama.1949.02900260018005.
5
Therapeutic drug monitoring of quetiapine in adolescents with psychotic disorders.
Pharmacopsychiatry. 2007 Mar;40(2):72-6. doi: 10.1055/s-2007-972573.
6
Endocrine and metabolic adverse effects of psychotropic medications in children and adolescents.
J Am Acad Child Adolesc Psychiatry. 2006 Jul;45(7):771-91. doi: 10.1097/01.chi.0000220851.94392.30.
7
Clinical drug monitoring in child and adolescent psychiatry: side effects of atypical neuroleptics.
J Child Adolesc Psychopharmacol. 2006 Jun;16(3):308-16. doi: 10.1089/cap.2006.16.308.
8
Anticonvulsant treatment for psychiatric and seizure indications among youths.
Psychiatr Serv. 2006 May;57(5):681-5. doi: 10.1176/ps.2006.57.5.681.
9
How the US drug safety system should be changed.
JAMA. 2006 May 3;295(17):2072-5. doi: 10.1001/jama.295.17.2072.
10
ADHD drugs and cardiovascular risk.
N Engl J Med. 2006 Apr 6;354(14):1445-8. doi: 10.1056/NEJMp068049. Epub 2006 Mar 20.
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